This invention relates to the field of endometrial ablation. More specifically the invention relates to devices and methods for performing endometrial ablations with chemical cauterizing agents.
According to current insurance company policies, endometrial ablation is considered medically necessary for women who meet certain selection criteria, including A. menorrhagia unresponsive to either 1. dilation and currettage or 2. hormonal therapy or other pharmacotherapy; and B. endometrial sampling has excluded cancer, pre-cancer, or structural abnormalities that require surgery; and C. pap smear and gynecologic examination have excluded significant cervical disease. Chemical ablation with trichloroacetic acid, cryoablation, electrosurgical ablation, laser, microwave endometrial ablation, radiofrequency ablation, and thermoablation are alternative approaches are considered by certain insurance companies to be medically appropriate and established.
Kucukozkan, et al., Chemical ablation of endometrium with trichloroacetic acid, Int J Gynaecol Obstet., 84(1):41-6, January 2004, concluded that endometrial ablation by trichloroacetic acid (TCA) may readily be performed as an alternative treatment method in the management of dysfunctional uterine bleeding (DUB).
However, except for the aforementioned Kucukozkan, et al., experiments in Turkey, the use of chemical cauterizing agent for endometrial ablation has not been carried out in clinical settings and has not been adopted by clinicians at all in the U.S. It is believed that Kucukozkan, et al., used cotton swabs to apply the chemical cauterizing agent to the endometrium in their experiments. To the inventor's knowledge, no special devices have been proposed or used by others to deliver a chemical cauterizing agent into the endometrial cavity.
There are numerous advantages to delivering a chemical cauterizing agent to the endometrial surface as a method of global endometrial ablation rather than currently available devices that require various energy sources, significant anesthesia, and/or direct visualization with hysteroscopy in order to ablate the endometrium.